Valsartan and hydrochlorothiazide in patients with essential hypertension. A multiple dose, double-blind, placebo controlled trial comparing combination therapy with monotherapy

Benz, JR; Black, H.; Graff, Alan; Reed, A.B.; Fitzsimmons, Sheila; Shi, Yang

doi:10.1038/sj.jhh.1000718

Cited by 107 publications

(80 citation statements)

References 16 publications

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“…The results of the present study demonstrated the antihypertensive efficacy of once-daily 160 mg valsartan in Chinese patients with mild to moderate hypertension. The blood pressure reductions observed in the current study (15.6/11.1 mmHg for office SBP/DBP following 10 weeks treatment) were comparable to those obtained in previous studies (7,11,(19)(20)(21)(22)(23), which examined single-drug or combination valsartan therapy in patients with mild to moderate hypertension over a similar time frame. In the latter studies, mean SBP reductions between 10.2 and 16.5 mmHg were observed, whereas mean DBP reductions were between 5.3 and 10.3 mmHg.…”

Section: Discussionsupporting

confidence: 76%

Efficacy and tolerability of once-daily 160 mg valsartan in Chinese patients with mild to moderate hypertension

Sun

Yang

Gao

et al. 2017

Experimental and Therapeutic Medicine

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Abstract. The present multicentre, prospective, open-label, single treatment arm study (Val-Perfect) examined the efficacy and tolerability of once-daily valsartan monotherapy (80 mg for two weeks, followed by 160 mg for eight weeks) in 195 Chinese patients with mild to moderate hypertension, using office, home, and ambulatory blood pressure (BP) monitoring. Significant mean reductions (P<0.0001) were observed in office BP from baseline to week 10, with mean sitting systolic BP (MSSBP) and mean sitting diastolic BP (MSDBP) values of 15.6±12.3 and 11.1±8.6 mmHg, respectively. The office BP control rate at week 10 was 56.9% (target MSSBP/MSDBP <130/80 mmHg for patients with type 2 diabetes or chronic kidney disease, <140/90 mmHg for others). Valsartan treatment significantly reduced mean 24-h SBP/DBP (-6.1/-4.4 mmHg; both P<0.0001) and mean home-monitored SBP/DBP (-13.3/-9.1 mmHg; both P<0.0001) at week 10. The incidence of adverse events (AEs) leading to discontinuation (1.5%) or drug-related AEs (3.1%) was low, with no instances of mortality or drug-related serious AEs. These results indicate that 160 mg valsartan is safe and effective at lowering BP in Chinese patients with mild to moderate hypertension. The significant reductions in office-based and out-of-office BP measures support the clinical relevance of moderate-dose valsartan monotherapy for effective 24-h BP control.

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Section: Discussionsupporting

confidence: 76%

Efficacy and tolerability of once-daily 160 mg valsartan in Chinese patients with mild to moderate hypertension

Sun

Yang

Gao

et al. 2017

Experimental and Therapeutic Medicine

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“…After further 4 weeks of valsartan monotherapy, they were reported to be approximately 0-1 mm Hg. 20,21 Although additional reductions up to 2-3 mm Hg have been reported for valsartan/hydrochlorothiazide combination, in most studies, the maximal antihypertensive effect was typically seen within 4 weeks. [20][21][22] This is reflected in the current prescribing information for valsartan and valsartan/HCTZ, which states that the antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks and persist during long-term therapy.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and safety of high-dose valsartan monotherapy in hypertension treatment: the ValTop study

et al. 2010

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Early combination therapy is increasingly recommended in hypertension management because of increased risk of adverse effects with high-dose monotherapy. However, this risk is not necessarily increased for high doses of angiotensin receptor blockers (ARB). ValTop study compared efficacy and safety of high vs. conventional dose of valsartan in hypertensive patients. ValTop was a controlled, randomized, double-blind trial. Of 6035 screened subjects, 4004 mild-to-moderate hypertensive patients (mean seated diastolic blood pressure (MSDBP) 90-109 mm Hg) started 4-week open-label treatment with valsartan 160 mg. Of them, 3776 were randomized to receive valsartan 160 mg (N¼1900) or 320 mg (N¼1876) o.d. for 4 weeks. In 28-week open-label extension study, all participating patients (N¼642) received valsartan 320 mg. Valsartan 160 mg reduced MSDBP by 10.0 mm Hg in the initial open-label phase. Further BP reductions in the double-blind phase were significantly (Po0.0001) greater in the 320 mg group than in the 160 mg group for MSDBP (1.6 ± 0.18 mm Hg vs. 0.5 ± 0.18 mm Hg) and mean seated systolic BP (3.3 ± 0.31 mm Hg vs. 0.7 ± 0.31 mm Hg). The size of the additional effect of the 320 mg dose on BP was similar in subjects controlled or not by the initial 160 mg dose. Adverse event (AE) rates were similar in both treatment groups, drug-related AEs occurring in o5% of subjects in each phase. High-dose valsartan is safe and effective in uncomplicated mild-to-moderate hypertension independently of the initial response to a moderate dose. High-dose ARB monotherapy may thus be a viable option in hypertension management.

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“…All combinations with the angiotensin receptor blockers were developed initially with HCTZ at a dose of 12.5 mg; these combinations typically show additive effects on blood pressure lowering regardless of which angiotensin receptor blocker was evaluated. 6,[19][20][21][22][23][24] Incremental BP-lowering effects have been observed with larger doses of hydrochlorothiazide, that is, 25 mg, in combination with the angiotensin receptor blockers, 6,19 which led to the development of the fixed-dose combination formulations used in our trial. In an earlier study by Benz and coworkers, 19 valsartan-HCTZ at a dose of 160/25 mg lowered the BP by 22/15 mm Hg compared with 18/ 14 mm Hg for valsartan-HCTZ at a dose of 160/ 12.5 mg. Trenkwalder et al 25 also showed that patients not controlled on valsartan-HCTZ 160/ 12.5 mg had an additional 8.4/8.3 mm Hg reduction in BP when the diuretic dose was increased to 25 mg.…”

Section: Principal Findingsmentioning

confidence: 99%

Impact of angiotensin receptor blockade in combination with hydrochlorothiazide 25 mg in 2121 patients with stage 1–2 hypertension

2009

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The antihypertensive effects of telmisartan 80 mg versus valsartan 160 mg, both combined with hydrochlorothiazide (HCTZ) 25 mg, were assessed in a pooled analysis from two large trials with identical study designs in patients with stage 1-2 hypertension. The trials were double-blind with a 4:4:1 randomization scheme to compare once-daily telmisartan 80 mg and HCTZ 25 mg versus once-daily valsartan 160 mg and HCTZ 25 mg versus once-daily placebo on reductions in clinic blood pressure (BP). The primary end point was changes from baseline in BP at the end of 8 weeks. In total, 2121 patients were randomized (telmisartan-HCTZ, 942, valsartan-HCTZ, 952, and placebo, 227) and had baseline seated BPs of 154/102 and 155/102 mm Hg in the two studies, respectively. Changes from baseline in BP after administration of telmisartan-HCTZ (À24.5/ À18.0 mm Hg) were significantly greater than for both placebo (À4.1/À6.5 mm Hg) and valsartan-HCTZ (À22.3/ À16.8 mm Hg) (versus placebo, Po0.0001 for systolic and diastolic BP; versus valsartan-HCTZ, P ¼ 0.0004 for systolic BP and P ¼ 0.0019 for diastolic BP). Adverse event rates were higher in the placebo group than in the active treatment groups (placebo, 41%, telmisartan-HCTZ, 30%, and valsartan-HCTZ, 30%, Po0.05). These data confirm that telmisartan-HCTZ at doses of 80/25 mg lowered systolic and diastolic BP to a greater extent than valsartan-HCTZ at doses of 160/25 mg in stage 1-2 hypertension. The magnitude of the BP-lowering effect provides support for the use of angiotensin receptor blockers with higher doses of a thiazide diuretic (25 mg) to improve hypertension control.

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Valsartan and hydrochlorothiazide in patients with essential hypertension. A multiple dose, double-blind, placebo controlled trial comparing combination therapy with monotherapy

Cited by 107 publications

References 16 publications

Efficacy and tolerability of once-daily 160 mg valsartan in Chinese patients with mild to moderate hypertension

Efficacy and tolerability of once-daily 160 mg valsartan in Chinese patients with mild to moderate hypertension

Effectiveness and safety of high-dose valsartan monotherapy in hypertension treatment: the ValTop study

Impact of angiotensin receptor blockade in combination with hydrochlorothiazide 25 mg in 2121 patients with stage 1–2 hypertension

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